Support for Regulation-Compliant Clinical Development of Therapeutics and Vaccines
🗓️ New Deadline: 15 September 2025
The Indian Council of Medical Research (ICMR), through its Clinical Studies and Trials Unit under the Division of Development Research, invites Expressions of Interest (EoIs) for clinical co-development of promising healthcare products — including drugs, biologics, and vaccines — ready for Phase I/II/III clinical trials.
If you’re a scientist, innovator, start-up, or academic researcher working on a candidate therapeutic product targeting a National Health Priority, this is your opportunity to access regulatory guidance, trial network support, and co-development pathways from India’s apex biomedical research organization.
🧪 Who Should Apply?
Researchers and teams working in India with promising regulatory-ready healthcare products (i.e., drugs, biologics, or vaccines—not diagnostics or medical devices) backed by preclinical efficacy and toxicity data.
Products may be:
- New chemical entities or biologics
- Vaccines
- Improved formulations or delivery routes of existing products
- Novel indications for approved products
Exclusions:
❌ Diagnostics
❌ Medical Devices
❌ Products with insufficient preclinical data
🎯 Objective of the EoI
To identify and support healthcare products that are:
- Clinically promising
- Compliant with Indian regulatory standards
- Ready for Phase I, II, or III clinical trials
- Targeted towards national health priorities
ICMR aims to bridge the gap between proof-of-concept and clinical application through its established trial networks (e.g., ICMR Phase I Trial Network and ICMR-INTENT Network).
📑 What’s Expected?
Applicants should:
- Be the original inventor or technology developer
- Possess or be ready to submit Test Batch License and IND/SND dossier
- Provide evidence of GLP-compliant preclinical studies
- Have identified or be working with a GMP manufacturing facility
- Be equipped or willing to engage with regulatory and clinical expertise
🗂️ Submission Process
- Go to the ICMR ePMS Portal
- Login and complete your profile
- Navigate to Proposal Submission > EOI > Add new EoI proposal
- Fill in the EoI form step-by-step as per Annexure I format
📅 Updated Timelines
| Milestone | Date |
|---|---|
| Call Launched | 1 July 2025 |
| Extended Deadline for Submission | 15 September 2025 |
| Review & Selection | Mid-September 2025 |
| Final Document Submission | Mid-October 2025 |
| Approval of Selected Proposals | Mid-November 2025 |
🧾 Review Criteria
All submissions will be evaluated based on:
- Innovation & Novelty
- Public Health Need & Impact
- National Priority Relevance
- Techno-Commercial Viability
- Regulatory Readiness
An independent committee constituted by ICMR will conduct the review. Final decisions will be made by ICMR’s competent authority.
✅ Expected Outcomes
- Fast-tracked clinical development of therapeutics & vaccines
- Strengthening of the evidence-based healthcare ecosystem
- Boost to translation-ready innovations from Indian labs and start-ups
📬 Contacts for Queries
- Technical support: 📧 po.epms@icmr.gov.in
- Scientific queries: 📧 sudipto.roy@icmr.gov.in
🔗 Full EoI Document with Annexure I Format (PDF)
🚀 Ready to Translate Your Innovation into a Real-World Solution?
If your healthcare product is ready to enter the clinical trial pipeline, ICMR’s clinical co-development support can help accelerate your path to regulatory approval and national impact.
📌 Apply by: 15 September 2025
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